Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of RTOG and KROG
Principal Investigator
In Kim, MD PhD
Status
Terminated
Date Opened To Accrual
July 26 2012
Date Closed to Accrual
September 12 2019
Date of Study Termination
May 20 2022
Disease Site
Breast [BR]
Breast
Phase
II
Developmental Therapeutics
No
Primary Objective
To determine if there is a signal for an increase in complete response (CR) rate in the measurable brain metastases at 12 weeks post RT (whole brain or SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.
Protocol and Other Documents:
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website
Data Collection Notice:
Data for this trial is being collected via the NRG/RTOG Data Center.
Patient Population
Pathologically (histologically or cytologically) proven diagnosis of invasive HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by FISH or SISH ≥ 2.0). At least one measurable, unirradiated parenchymal brain lesion.
Target Accrual
143
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.